Nov. 20, 2012 — Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).

Whether the pill should go over-the-counter has been debated at least since the early 1990s, says Dan Grossman, MD. He’s vice president of research at Ibis Reproductive Health, a research and advocacy organization. His research is cited in the opinion.

“I think it is a bold move,” Grossman says. “There haven’t been any big surveys of ob-gyns about what they think about this. I’m really proud of ACOG for standing by the evidence.”

A growing body of “compelling” research supports making the switch, he says.

David Grimes, MD, a long-time reproductive rights advocate, called the ACOG opinion “highly scientific” and “strongly proactive in terms of public health.” Grimes is a clinical professor of obstetrics and gynecology at the University of North Carolina.

Unintended Pregnancies in the U.S.

The rate of unintended pregnancies in the U.S. hasn’t changed in the past 20 years, according to ACOG. It accounts for half of all pregnancies “and remains unacceptably high,” states ACOG’s Committee on Gynecologic Practice. The committee’s opinion appears in Obstetrics & Gynecology, which is published by the organization.

“Access and cost issues are common reasons why women either do not use contraception or have gaps in its use,” the committee states.

Oral contraceptives are highly effective if taken properly. In a report released last month, the CDC’s National Center for Health Statistics said the pill was preferred by 28% of women of reproductive age who used contraceptives.

One concern about allowing a prescription drug to be sold over the counter is whether people can safely decide on their own to take the medication. But the ACOG committee says several studies have shown that women are capable of self-screening for conditions or other factors that would make it unsafe to take the pill.

Except for smokers 35 and older, who are at an increased risk of blood clots from oral contraceptives, “taking the pill is safer than not” taking the pill, Grimes says. He was not involved in writing the ACOG opinion.

Cost of Oral Contraceptives

Another concern about switching drugs from prescription to over the counter is extra costs for the patient. Insurance covers prescription drugs but not over-the-counter drugs.

“It is possible that some women might be adversely affected by changing to over-the-counter OCs [oral contraceptives] if they lose insurance coverage for their preferred contraceptive method,” the ACOG committee writes.

The health reform law requires health plans to cover preventive services such as FDA-approved contraceptives and eliminates co-pays for them. But it’s not yet clear whether that would apply to over-the-counter birth control pills, Grossman says.

The FDA could on its own decide to make oral contraceptives available without a prescription. But such switches usually are instigated by drug companies, Grossman says. He says he knows of no drugmakers seeking to sell the pill over the counter.

And according to FDA spokeswoman Stephanie Yao, for a switch to occur the FDA needs to determine whether keeping a drug available only by prescription is necessary to protect the public’s health. The FDA might require the drugmaker to do additional research, such as a study to determine whether patients can understand labeling directions on their own, Yao says.

Drugmakers’ Perspective

Several drugmakers weighed in on the debate.

“Bayer believes that the decision to use hormonal contraceptives should be made between a woman and her health care provider,” says Rosemarie Yancosek, spokeswoman for Bayer HealthCare Pharmaceuticals, which markets such birth control pills as Yaz and Natazia.

William Foster, a spokesman for Janssen Pharmaceuticals, which markets the Ortho birth control pills, would not say whether his company plans to seek to make the contraceptives available over-the-counter.

“This is a very complex public health issue that has been debated for years by family planning organizations, women’s health groups, and physicians,” Foster says. “Janssen believes the [FDA] should consider the perspective of each of these organizations” in determining whether over-the-counter birth control pills are in the best interest of public health.